Premier Heart's MCG system is founded on the principles of evidence-based medicine. As such, we believe that the best way of demonstrating the accuracy and capabilities of our technogy is through well designed double-blind clinical trials coupled with ongoing analysis and review of our system's performance in daily clinical practice.

This page presents an overview of our peer-reviewed clinical trial results. It includes summary data for each trial as well as electronic copies of the peer-reviewed articles detailing the methods used in each study.

MED-FIT Trial (Kawaji et. al.) — Japan Original Trial Article Post-Hoc Analysis (Translation) Letter to the Editor by Drs. Imhoff & Rainford Author's Response This study published in the Annals of noninvasive Electrocardiology compared MCG analysis to Fractional Flow Reserve (FFR) for purposes of detecting clnically significant coronary ischemia. Of note this trial initially indicated poor diagostic performance due to the use of MCG Severity Score alone. In the post-hoc analysis (conducted by the original authors using current guidance for interpretation of MCG reports) an overall accuracy of 81.3% was achieved, with sensitivity/specificity of 90.6%/59.3% respectively. The importance of the session analysis methodology for MCG and the key differences between anatomical (angiographic) measurements and functional (MCG, Electrophysiological) measurements are highlighted in the letter to the editor reproduced above. Results were published online to Wiley Online Library in Annals of Noninvasive Electrocardiography (2014, 2015) and in Clinical Medicine Vol. 31 No. 1 (January) 2015

Takeshita et. al. — Japan Trial Article This study compared the results from MCG with the Classical and Functional SYNTAX scores of 87 patients. This study showed a strong correlation between MCG Severity Score and the Classical / Functional SYNTAX scores, suggesting that MCG may be useful in identifying functionally significant ischemia and also in reducing unnecessary CAGs. Results were published online to Wiley Online Library in Catheterization and Cardiovascular Interventions 00:00-00 (2015)

Summary Data: Clinical Trials 2000—2004

This summary includes statistical information from our clinical trials between 2000 and 2004, representing a sample of over 1,000 patients in three major geographic regions (North America, Europe and Asia).

All studies in this group were performed in accordance with Premier Heart's Westchester Study Protocol, utilizing standard double-blind testing and independent verification of results.

Overall sensitivity across these studies was 91% (specificity 83.8%, positive predictive value 77.6%, negative predictive value 92.4%).
Meta Analysis Article - Published in the International Journal of Medical Sciences 2009; 6(4) pp 143-144.

The trials below were conducted with our first generation 3DMP and 3DMP/mfEMT software suite — MCG shares the underlying diagnostic technology and produces identical results.

Westchester Medical Center — New York, USA Trial Article This study compared the results from MCG with the results of coronary angiograms in a random sample of 136 patients. This study showed a sensitivity of 93.3% (specificity 83%, positive predictive value 91.2%, negative predictive value 86.7%). Results were published in Heart Disease 2002; 4: pp 2-12.

Siegburg Heart Center — Siegburg, Germany Two studies were performed at the Siegburg heart center in Siegburg, Germany, evaluating MCG in patient populations with and without a history of revascularization. Trial Article Monitor Letter The first study evaluated the use of MCG in a set of 423 patients with no prior history of coronary revascularization. In this study our technology showed a sensitivity of 89.1% (specificity 81.1%, positive predictive value 79%, negative predictive value 90%). Results were published in International Journal of Medical Sciences 2007 4(5): pp 249-263. Trial Article Monitor Letter The second study evaluated the ability of our technology to deal with the special challenges of patients with a prior history of coronary revascularization, testng in a sample of 172 patients. In this study our technology showed a sensitivity of 90.9% (specificity 88%, positive predictive value 62.7%, negative predictive value 97.8%). Results were published in International Journal of Medical Sciences 2008 5(2): pp 50-61.

Asian Multicenter — Four sites Trial Article Monitor Letter This study was conducted across four centers in Asia with a sample of 189 patients (including patients with and without a history of prior revascularization). This study yielded a sensitivity of 94.8% (specificity 86.6%, positive predictive value 78.4%, negative predictive value 97.1%). Results were published in Congestive Heart Failure 2008 14: pp. 251-260